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Model Number NGP680301 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wrinkling (2613); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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Weight, ethnicity: unknown, not provided.Date of event is unknown.Best estimated dates are from (b)(6) 2021.Serial number is unknown as it was not provided.Unique identifier (udi) number unknown as serial number was not provided.Concomitant medical products: lens model dib00u0230 sn: (b)(4).Left eye.Manufacturer date is unknown as serial number was not provided.Although several attempts were made, the clinic is reporting this adverse event only and did not request or require field service or clinical support.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Event Description
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It was reported that several patients developed post-op complications after the implantation of dcboo and or diboo intraocular lenses with the use of the signature pro equipment.The date of surgeries was between (b)(6) of 2021.The post op complications reported were edema with various grades, fibrin, cells graded from trace to 3+, folds with increase, and retinal hemorrhage.The following is for edema and folds.A (b)(6) year-old male developed edema and folds on the left eye after cataract extraction and the implantation of intraocular lens¿ model diboo with the use of the signature pro equipment.Although several attempts were made, no service was requested and no additional information was provided.
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Manufacturer Narrative
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Additional information: section b5: through follow up, it was determined the patient experienced toxic anterior segment syndrome (tass) section h6-health effect clinical code 4469 - toxic anterior segment syndrome (tass) device evaluation: a johnson & johnson representative visited the site location.After discussions with the treating surgeon, the surgeon comments t are that believes this event is a sterilization issue with some of surgery center¿s instruments etc.The j&j representative reviewed the directions for use (dfu) of how to sterilize the handpieces with the administration of the operating room (or), staff, and surgeon.At this time, no further occurrences have been reported.As stated in initial report, a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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